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Zeltiq Aesthetics Inc.: FDA-registered device maker in Dublin, CA, United States, 12 510(k) clearances

Name: Zeltiq Aesthetics Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Zeltiq Aesthetics Inc. is registered with the FDA (registration 3009974688) in Dublin, CA, United States. It lists 2 device types. The FDA files 12 510(k) clearances under its listings, the newest dated September 12, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009974688
Address: 5996 Gleason Drive, Dublin, CA, United States, 94568
Owner or operator: ZELTIQ Aesthetics, Inc. (10025698)
Roles: Manufacturer
First device listed: December 17, 2010
Registered through: 2026
Brand names listed: CoolSculpting Elite System, CoolSculpting System, DPRO, EnDoucer Dermolissage, SP3, Silk Peel Dermalinfusion, SilkPeel MD, SilkPeel Pro and more

Devices it lists

Device	Product code	Class	Role	Source
Brush, Dermabrasion, Powered	GFE	1	Manufacturer	accessdata.fda.gov
Dermal Cooling Pack/Vacuum/Massager	OOK	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 12, 2024	K233732	CoolSculpting Elite System	OOK	Substantially Equivalent	Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics	accessdata.fda.gov
November 5, 2021	K212707	CoolSculpting Elite System	OOK	Substantially Equivalent	Zeltiq Aesthetics, Inc.	accessdata.fda.gov
January 21, 2020	K193566	ZELTIQ CoolSculpting System	OOK	Substantially Equivalent	Zeltiq Aesthetics, Inc.	accessdata.fda.gov
January 14, 2019	K183514	ZELTIQ CoolSculpting System	OOK	Substantially Equivalent	Zeltiq Aesthetics, Inc.	accessdata.fda.gov
August 29, 2018	K181740	ZELTIQ CoolSculpting System	OOK	Substantially Equivalent	Zeltiq Aesthetics, Inc.	accessdata.fda.gov
July 7, 2017	K171069	ZELTIQ CoolSculpting System	OOK	Substantially Equivalent	Zeltiq Aesthetics, Inc.	accessdata.fda.gov
November 21, 2016	K162050	ZELTIQ CoolSculpting System	OOK	Substantially Equivalent	Zeltiq Aesthetics, Inc.	accessdata.fda.gov
March 23, 2016	K160259	ZELTIQ CoolSculpting System	OOK	Substantially Equivalent	Zeltiq Aesthetics, Inc.	accessdata.fda.gov
September 22, 2015	K151179	ZELTIQ CoolSculpting System	OOK	Substantially Equivalent	Zeltiq Aesthetics, Inc.	accessdata.fda.gov
January 26, 2015	K142491	ZEL TIQ CoolSculpting System	OOK	Substantially Equivalent	Zeltiq Aesthetics, Inc.	accessdata.fda.gov
April 9, 2014	K133212	ZELTIQ COOLSCULPTING SYSTEM	OOK	Substantially Equivalent	Zeltiq Aesthetics, Inc.	accessdata.fda.gov
August 24, 2010	DEN090002	ZELTIQ AESTHETICS DERMAL COOLING DEVICE	OOK	Unknown	Zeltiq Aesthetics	accessdata.fda.gov

Compare with other makers

Updated September 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.